Home / Recalls / LUPIN SOMERSET / D-0927-2018

D-0927-2018 Class II Terminated

Recalled by LUPIN SOMERSET — Somerset, NJ

Recall Details

Product Type: Drugs
Report Date: July 18, 2018
Initiation Date: June 28, 2018
Termination Date: March 6, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3456 cartons

Product Description

Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, UPC 343386-450-114, NDC 43386-450-11

Reason for Recall

Subpotent Drug and Failed Content Uniformity.

Distribution Pattern

Nationwide within the US

Code Information

Lot#: S700065, Exp. 02/2019; 700619, Exp. 08/2019

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